BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURO FEMORAL COMPONENT CEMENTED F2L

    MDR report key: 5818149 · Received July 23, 2016

    Report

    Report Number
    3005673311-2016-00112
    Event Type
    Death
    Date Received
    July 23, 2016
    Date of Event
    June 21, 2016
    Report Date
    July 22, 2016
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    KRO
    PMA / PMN Number
    K101815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. EVALUATION: ON GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). TWO YEAR POST OPERATIVE THE PATIENT HAD REVISION SURGERY DUE TO FEMUR BREAKAGE. PRIOR TO SURGERY THE PATIENT EXPERIENCED RETRO-PATELLAR PAIN. NO MALPOSITION OF FIRST SURGERY. THE SURGERY WAS SUCCESSFUL. PATIENT DIED POST-OPERATIVELY CAUSED BY A HEART ATTACK. REVISION SURGERY DATE: (B)(6) 2016. IMPLANTED DATE: 2014. CONCOMITANT MEDICAL PRODUCTS: NR293K / FEMUR EXTENS.STEM 6° D18X77MM CEMENTED ((B)(4)); LOT NUMBER: 51833436; PRODUCTION DATE: 04/27/2012; EXPIRATION DATE: 02/01/2022. NR400K / NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR.((B)(4)); LOT NUMBER: N/I; PRODUCTION DATE: N/I; EXPIRATION DATE: N/I. NB013K / ENDURO TIBIAL COMP.OFFSET CEMENTED T3 ((B)(4)); LOT NUMBER: 51800741; PRODUCTION DATE: 11/22/2011; EXPIRATION DATE: 10/01/2016. NR193K / TIBIA OFFSET STEM D18X52MM CEMENTED ((B)(4)); LOT NUMBER: 51830962; PRODUCTION DATE: 04/13/2012; EXPIRATION DATE: 02/01/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471270 ENDURO FEMORAL COMPONENT CEMENTED F2L ALLOGRAFT KRO AESCULAP IMPLANT SYSTEMS NB015K 51846000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death